The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Promos Modular Shoulder System.
| Device ID | K113012 |
| 510k Number | K113012 |
| Device Name: | PROMOS MODULAR SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
| Contact | Megan Bevill |
| Correspondent | Megan Bevill SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-11 |
| Decision Date | 2012-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611996127225 | K113012 | 000 |
| 07611996127218 | K113012 | 000 |
| 07611996127201 | K113012 | 000 |
| 07611996127195 | K113012 | 000 |
| 07611996120554 | K113012 | 000 |
| 07611996120547 | K113012 | 000 |
| 07611996120530 | K113012 | 000 |
| 07611996120523 | K113012 | 000 |